How To Write The Harmonised Chemical Safety Plan

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Classification, labelling and packaging

according to CLP

Studiedag LAB 3th October 2013

Dr Saskia Walraedt

Sr Advisor

Projectleider VLARIP

[email protected]

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Content



Introduction to CLP



General principles on classification

of mixtures



Using harmonised classification

and labelling



Action plan

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Abbreviations

ATE : acute toxicity estimate

ATP: adaptation to technical progress C&L: classification and labelling

CLP : classification, labelling and packaging CMR : carcinogenic, mutagenic, reprotoxic DPD : Dangerous product directive

DSD : dangerous substance directive DU : downstream user

EC: European Commission

ECHA : European Chemicals Agency GCL : generic concentration limit GHS: Globally Harmonised System LC: lethal concentration

MS : member states

NOEC : no observed effect concentration OJ: official journal

RAC : Risk Assessment Committee

REACH : registration, evaluation, authorisation and restriction of chemicals SCL : specific concentration limit

STOT SE : specific target organ toxicity single exposure STOT RE : specific target organ toxicity repeated exposure

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CLP – the basics

• European implementation of the Globally Harmonised

System (GHS), developed by UN

• But also EU specific

• List of EU harmonised classifications (annex VI)

• Notification of dangerous mixtures to national anti-poison centres

• Notification of the classification & labeling of substances to ECHA for the C&L inventory

• Regular updates via ATP

• Extension of the Annex VI list

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GHS (VN) CLP (EU )

Binding? no yes, EU regulation

Classification yes yes GHS + EUH

Labelling yes yes

SDS yes no, REACH

Packaging no yes

Notification poison centres no yes

Notification C&L no yes

GHS vs CLP

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CLP - a living regulation

• Extension of Annex VI list of harmonised classifications

•

1

ste

_{ATP to CLP : inclusion of 30st en31st ATP to DSD}

Consolidated version:

http://ecb.jrc.ec.europa.eu/classification-labelling/clp/

•

3

e

_ATP

• First new harmonised classifications added

• http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:179:

0003:0010:NL:PDF

•

5

e

_ATP

• Notification to WTO

• expected Q2 2013

• EiF 20 d after publication in OJ

• The provisions will apply from 1

st

_{January 2015.}

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CLP- a living regulation

• Adoption to the biannual revision of GHS

•

2

de

_{ATP (regulation 286/2010)}

• Adoption to 3th revision of GHS

•

4

e

_{ATP (regulation}

_487/2013)

• Adoption

to 4th revision GHS

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Adaptation to revisions of GHS

• New classifications

• New test methods

• Changes to H statements

• Changes to P statements

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Impact on own classifications, labelling, SDS,

software….

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* Indien al op de martkt met EU-etiket voor de deadline M E N G S E LS S T O F F E N indeling volgens CLP optie indeling volgens EU 67/548

verplicht indeling volgens

EU 67/548 verplicht

indeling volgens CLP verplicht* indeling volgens EU 67/548 verplicht*

indeling volgens CLP verplicht

indeling volgens EU 1999/45

verplicht

indeling volgens CLP optie

indeling volgens EU 1999/45 verplicht

indeling volgens CLP verplicht

* Zowel indeling volgens CLP als volgens EU 67/548 te vermelden in SDS

M E N G S E LS S T O F F E N etikettering volgens EU 67/548 verplicht

etikettering volgens CLP verplicht

etikettering volgens EU 67/548 optie* etikettering volgens CLP verplicht etikettering volgens EU 1999/45 verplicht etikettering volgens CLP verplicht etikettering volgens EU67/548 of CLP

(afh. van de indeling)

1 etiket!

etikettering volgens EU67/548 of CLP

(afh. van de indeling)

1 etiket! etikettering volgens EU 67/548 optie*

overgangsbepalingen CLP mbt indeling

overgangsbepalingen CLP mbt etikettering

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CLP for mixtures – where to start

10 1/6/2015 Re- formula-tion and appro-vals Finali-sing C&L, modif. SDS Notifica-tion poison centres Label-ling and packa-ging knowled -ge CLP? CLP C&L ingre-dients Estima-ting C&L own mixture

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Collecting

data

Verification

against

criteria

classification

Labelling

Packaging

Notification

poison centre

Notification

C&L

CLP – how it works

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Collecting data for own mixtures

• Fysical properties : classification on mixtures

• Human tox : no animal testing for C&L!

• aquatoxicity : based on aquatox data of ingredients

12

Original concentration of a substance Max deviation

< of = 2,5% ca 30%

2,5 < C < of = 10% ca 20%

10 < C < of = 25% ca 10%

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DATA

• Use available data

ANNEX VI

• Check Annex VI tabel 3.1 for harmonised C&L

Conversio n table

• Use the conversion table

(annex VII) for each substance not on annex VI and for which no data are available

DATA

• Use available information on the mixture

• Use data of comparable mixtures

Componente n

• Use information on C&L of substances to classify the mixture

Conversie-tabel

• Use conversion table (annex VII) on DPD classification of the mixture till 1/6/2015

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Fysische gevaren

DPD

Explosive Oxidising

Flammable, highly flammable, extremely flammable

CLP

Explosive

Flammable gas

Chem unstable gases Aerosols Oxidising gas Pressurised gas Flammable liquid Flammable solid Self react Pyroforic liq Pyroforic solid Self heating Water reacting Oxidising liquid Oxidising solid Organic peroxides Metal corrosives 14 CLP :

No 1-to-1 conversion possible Physical state important

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Flammable Liquids

15 °C flashpoint CLP DSD/DPD 21 23 55 60 Cat. 2 V_p < 23 °C & T_k > 35°C Cat. 1 V_p < 23 °C & T_k < 35°C Cat. 3 23 °C < Vp < 60°C Cat. 4 60 °C < Vp < 93°C 93 GHS

danger _warning _warning

F+, _,R12

Vp <0 & Tk < 35°C R10

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Humane tox

DPD

Harmful, toxic, very toxic

Corrosive

Irritant

Sensitizer

CMR

CLP

Acute tox oral

Acute tox dermal

Acute tox inhalation

Skin corr or irr

Eye damage or irr

Resp sensitiser

Skin sensitiser

CMR

STOT SE

STOT RE

Asp tox

₁₆ CLP New classes

New concept for calcution acute tox of mixtures based on ATE More stringent

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Acute toxicity estimate : ATE

• ATE = acute toxicity estimate

• To calculate acute tox of mixtures

• If available ATE = LC50

• If LC50 not available and only category known, use ATE of

table 3,1,2

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18

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• When data available on all substances

ATE mix = 100 / (∑ Ci / ATEi)

met

Ci = concentration of substance i (% w/w of % v/v)

i = the individual substances 1 to n

n = number of substances

ATEi = acute toxicity estimate for substancei

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



n ATEi

Ci

ATEmix

100 (Formule 3.1.3.6.1.)

n

Acute toxicity for mixtures

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Tabel 3.1.1 : determining acute tox category

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Blootstellings-route Categorie 1 Categorie 2 Categorie 3 Categorie 4

Oraal (mg/kg

lichaamsgewicht) ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000 Dermaal (mg/kg

lichaamsgewicht) ATE ≤ 50 50 < ATE ≤ 200 200 < ATE ≤ 1000 1000 < ATE ≤ 2000 Gases (ppmV 1 ₎ _{ATE ≤ 100} _{100 < ATE ≤}

500 500 < ATE ≤ 2500 2500 < ATE ≤ 20 000 Dampen (mg/l) ATE ≤ 0.5 0.5 < ATE ≤ 2.0 2.0 < ATE ≤

10.0 10.0< ATE ≤ 20.0 Stofdeeltjes en

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• If acute tox is not known for all substances



Substance with unknown acute tox ≤ 10 %

Formule 3.1.3.6.1.



Substance with unknown acute tox > 10 %

ATE mix = (100 – (∑C_unknown _if > 10 %) ) / (∑ Ci / ATEi)

21 n

Acute toxicity

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Generic concentration limits (GCL)

22

DPD DPD Conc

limit

CLP CLP conc. limit

Corr C, R34 10% Skin corr 1B en 1C 5%

Corr C, R35 5% Skin corr 1A 3%

Irr Xi, R38 20% Skin irr cat. 2 10%

Irr XI, R36 20% Eye irr 2A 10%

Irr Xi, R 41 10% Eye dam 1 3%

Repr R60 of R61 0,5% Repr 1 0,3%

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environment

DPD

Aq tox acute

Aq tox chronic

Ozone depletion

CLP

Aq Tox Acute

Aq tox Chronic

Ozone depletion

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New calculation rules

New concept of M-factor for class 1

substances

Use of EC50 and NOEC values

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Annex VI : for which substances?

• Only for substances or groups of substances

• Group 1

:

• CMR cat 1A,1B or 2

• respiratory sensitisers cat 1

• When EU considers that harmonisation is required

• To be submitted by the MS (or industry)

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Annex VI : for which substances?

• Group 2:

• Voor plant protection products and biocides

• Only to be submitted by MS

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Specific concentration limits (SCL)

• In annex VI or

• Determined by registrant, importer or DU based on data

• To be indicated in section 3 of SDS

• Always check first if SCL available

• Priority : SCL > GCL, indepent of SCL value higher or lower

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27 opleiding REACH en CLP

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ATP’s adapting Annex VI

28 Registry of Intentions Public consultati on RAC advise EC decision ATP in OJ Follow up as soon as substance on RoI

Impact own business? Reformulation required?

To be adopted even if still on DPD ! (before 6/2015)

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CLP for mixtures – where to start

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GEVAARLIJK VOOR HET AQUATISCH MILIEU GHS09

CLP pictograms

30h EXPLOSIEF GHS01 ONTVLAMBAAR GHS02 OXIDEREND GHS03 CORROSIEF GHS05 GIFTIG GHS06

!

IRRITEREND, SENSIBILISEREND, SCHADELIJK GHS07 LANGE TERMIJN GEZONDHEIDSGEVAARLIJK GHS08

GASSEN ONDER DRUK GHS04

http://www.unece.org/trans/danger/publi/

ghs/pictograms.html

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Labelling

31 Hazard statements Precautionary statements Max 6 statements How to select?

• Use priority guidelines ECHA guidance

• Avoid duplicates

• Consider at least 1 P statement per hazard

• Selling to industrial users/ professional/consumers?

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Multiple languages OK but keep it readable!

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CLP for mixtures – where to start

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Notification to Be poison centre

1. According EU directives and regulations

• Gevaarlijke preparaten (KB 11/01/1993 - vervangen door KB van 17/07/2002)  art. 17 DPD

• CLP (art 45)

• Pesticides (KB 28/02/1994) • Biocides (KB 5/09/2001)

2. Additional nationale regulations

• Cosmetics (KB 15/10/1997)

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Melding anti-gifcentrum :

http://www.poisoncentre.be/rubrique.php?id_rubrique=9

0&lang=nl

Opleidingscyclus CLP voor experten 2013 pag. 35

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CLP for mixtures – where to start

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Logistics

• Consumer market ? Other packaging may be required!

• New software labelling?

• New color printer or preprinted label?

• Warehouse organisation :

• Mixtures which were previously not classified may become CLP classified!

• E.g. flammables, irritating…

• Packaging requirements

• For consumer products : tactile warnings and child proof caps?

• If ADR labelling required :

• Inner label : CLP, outer label : ADR and CLP optionally

• Single packaging : CLP picto may be omitted if = ADR labels

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CLP for mixtures – a team effort

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EHS – classification impact? IT dept – software impact?

Logistics dpt – labelling and packaging impact?

R&D dpt – reformulation required? Marketing/sales dpt – commercial impact?

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Conversion to CLP

• CLP training, build a CLP team

• Allow time

• Plan budget

• Discuss with suppliers (of mixtures)

• Inform internally (sales, purchasing, production,

warehouse…) and externally (customers and

suppliers)

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More info on ECHA website

40 Opleidingscyclus CLP voor experten 2013

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ECHA guidance

• http://echa.europa.eu/web/guest/guidance-documents/guidance-on-clp

41 Opleidingscyclus CLP voor experten 2013

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Usefull links

• http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

• http://ec.europa.eu/enterprise/reach/ghs/index_en.htm

• http://ecb.jrc.ec.europa.eu/classification-labelling/

• http://www.ghs-helpdesk.nl/

• http://ec.europa.eu/enterprise/sectors/chemicals/documents/classific

ation/index_en.htm

• http://www.napofilm.net/en/napos-films

• http://www.youtube.com/watch?v=PjJiLPeeFsE

• http://www.youtube.com/watch?v=BrcrICA5XIs&feature=related

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Belgian helpdesk CLP

• Federale overheidsdienst (FOD) Volksgezondheid,

Veiligheid van de Voedselketen en Leefmilieu

Eurostation II

Victor Hortaplein, 40 bus 10

1060 Brussel

Contact Center : +32 (0)2 524.97.97

E-mail : [email protected]

• http://www.health.belgium.be/eportal/Environment/Chemi

calsubstances/index.htm

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Conclusions

Follow up on the adaptation of other legislations,

i.e. SEVESO, VLAREM…

Make an action plan for the conversion of own

production to CLP

Regular changes to the classification of mixtures

possible, even before switching to CLP

new data from the REACH registrations of the substances new harmonised classifications

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Disclaimer

Alle gegevens op dit document worden door essenscia vzw/essenscia vlaanderen met de grootste zorgvuldigheid samengesteld. Voor deze informatie worden enkel betrouwbare bronnen aangewend. Ondermeer door de snelle evolutie van de behandelde materie blijft de mogelijkheid bestaan dat de gegevens toch niet volledig accuraat zijn, daarom wijst essenscia vzw/essenscia vlaanderen elke aansprakelijkheid voor fouten of onvolkomenheden af.